Label: information for the user

Zolpidem Viatris 10 mg film-coated tablets EFG

zolpidem tartrate

Read this label carefully before starting to take this medicine, as it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.

• This medicine has been prescribed only for you and should not be given to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this label. See section 4.

Zolpidem is a hypnotic that belongs to a group of medications known as benzodiazepine analogs.

Zolpidem is used for the short-term treatment of insomnia in adults, in situations where insomnia is weakening or causing severe anxiety.

Do not take this medication for a long time. Treatment should be as short as possible, because the risk of dependence increases with the duration of treatment.

Zolpidem is indicated for sleep rhythm disorders and all forms of insomnia, especially when there are difficulties in falling asleep, either initially or after a premature awakening.

Do not takeZolpidem Viatris

• If you are allergic to zolpidem, the benzodiazepine group in general, or any of the other components of this medication (listed in section 6).
• If you have acute and/or severe respiratory difficulties.
• If you have severe muscle weakness (myasthenia gravis).
• If you have sleep apnea (a condition in which your breathing is interrupted for short periods while you are asleep).
• If you have any liver or kidney disorders.
• As long-term treatment. Treatment should be as short as possible, as the risk of dependence increases with the duration of treatment.
• If you have experienced sleepwalking or other unusual behaviors while asleep (such as driving, eating, calling, or having sex, etc.) without being fully awake after taking zolpidem or other medications containing zolpidem.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Zolpidem Viatris.

• Your doctor should identify the causes of insomnia whenever possible and treat underlying factors before prescribing zolpidem.
• After taking zolpidem, ensure that you can have 8 hours of uninterrupted sleep to reduce the risk of anterograde amnesia (not remembering what happened while you were awake).
• If you have ever had any mental disorders or problems with substance abuse or dependence on alcohol or drugs.
• Risk of dependence: the use of zolpidem may lead to the development of physical and psychological dependence. The risk of dependence is higher when zolpidem is used for more than 4 weeks. The risk of abuse and dependence is higher in patients with a history of mental disorders and/or substance abuse.
• To minimize the risk of dependence, consider the following precautions:

• The medication should be taken only under medical prescription (never because it has worked in other patients) and should never be recommended to others.
• Do not increase the prescribed doses, or prolong the treatment longer than recommended.
• Consult your doctor regularly, so that they can decide whether to continue treatment.

Once physical dependence has developed, abrupt discontinuation of treatment will be accompanied by a withdrawal syndrome, which may include restlessness, anxiety, headache, muscle pain, confusion, irritability, and tension. Therefore, it is recommended to gradually reduce the dose, according to the doctor's instructions.

In severe cases, the following symptoms may appear: altered perception of reality, depersonalization, decreased tolerance to usual sounds (hyperacusia), numbness and tingling in the extremities, hypersensitivity to light, noise, and physical contact, hallucinations, or epileptic seizures.

• Rebound insomnia: in some cases, after discontinuing treatment, a transient syndrome may occur in which the symptoms that led to starting treatment reappear, but in an increased form. They may be accompanied by other reactions such as mood changes, anxiety, sleep disorders, and restlessness. It is essential to know that there is a possibility of this rebound phenomenon occurring, in order to minimize the anxiety that may be caused by the appearance of these effects when discontinuing treatment. In the case of short-acting hypnotics/sedatives, the withdrawal syndrome may appear within the dosing interval. The probability of rebound insomnia is higher with abrupt withdrawal. Therefore, it is recommended to gradually reduce the dose, according to the doctor's instructions.
• Other psychiatric and "paradoxical" reactions such as restlessness, agitation, worsening of insomnia, irritability, aggression, delirium, anger attacks, nightmares, psychosis, hallucinations, abnormal behavior, and other conduct alterations occur with zolpidem. Treatment should be suspended when these reactions appear. These reactions are more likely to occur in elderly patients.
• Zolpidem may cause sleepwalking or other unusual behaviors while asleep (such as driving, eating, calling, or having sex, etc.) without being fully awake, some of which have been associated with severe injuries or even death. The next morning, you may not remember anything that happened during the night. If you experience any of the above symptoms, discontinue zolpidem treatment immediately and contact your doctor or healthcare professional, as these sleep behaviors may put you and others at risk of serious injury.

Drinking alcohol or taking other sedating medications with zolpidem may increase the risk of these sleep behaviors.

The use of zolpidem with alcohol and other central nervous system-acting medications, or taking higher doses than recommended, may increase the risk of these behaviors. Your doctor should consider discontinuing treatment in these cases, as the risk may be significant for both you and others.

• This medication may cause drowsiness and a decrease in consciousness, which may cause falls and, consequently, cause serious injuries.

• After repeated use for several weeks, some tolerance to the product may develop, resulting in a loss of hypnotic efficacy.
• If you have a history of substance or alcohol dependence, do not take zolpidem unless your doctor advises you to.
• If you have congenital long QT syndrome, your doctor should carefully consider the benefit-risk ratio before starting zolpidem treatment.
• In patients with mental disorders (psychosis), its use is not recommended as primary treatment.
• If you have suicidal tendencies and depression, use with extreme caution. Consult your doctor before using this medication, as it may unmask an existing depression. Some studies have shown an increased risk of suicidal ideation, attempt, and suicide in patients taking certain sedatives and hypnotics, including this medication. However, it has not been established whether this is caused by the medication or if there may be other reasons. If you have suicidal thoughts, contact your doctor as soon as possible for additional medical advice.
• If you have any liver disorders or respiratory problems, your doctor will decide whether to take a lower dose of zolpidem or not to take it.
• In patients with severe liver failure, zolpidem should not be taken, as it may contribute to the development of encephalopathy (brain disease).
• Do not take zolpidem with opioids (pain medications such as morphine or codeine) unless your doctor prescribes it, as there may be a risk of sedation, respiratory depression, coma, or even death (see "Other medications and Zolpidem Viatris"). If your doctor finally prescribes zolpidem with opioids, they should prescribe the minimum effective dose and for the shortest duration of concomitant use. Your doctor will monitor the appearance of signs and symptoms of respiratory depression and sedation.
• In elderly patients, the dose should be reduced. See section "3. How to take Zolpidem Viatris".

Altered psychomotor function the next day(see also "Driving and operating machines")

Like other hypnotics/sedatives, zolpidem has depressant effects on the central nervous system.

The next day after taking zolpidem, there may be an increased risk of altered psychomotor function, including impaired ability to drive, if:

• You take this medication with less than 8 hours of margin before performing activities that require a state of alert mental.
• You take a higher dose than recommended.
• You take zolpidem with another central nervous system depressant or another medication that increases zolpidem concentration in the blood, combined with alcohol or illicit substances.

Take the dose once and immediately before going to bed at night.

Do not take another dose during the same night.

Children and adolescents

Do not administerzolpidem to children and adolescents under 18 years old.

Other medications and Zolpidem Viatris

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

This is extremely important, as the simultaneous use of multiple medications may increase or decrease their effect.

Therefore, do not use other medications at the same time as zolpidem unless your doctor is informed and approves it in advance.

• If you take zolpidem with the following medications, the effects may be potentiated, such as drowsiness or altered psychomotor function the next day, including impaired ability to drive:

• Medications for some mental disorders (antipsychotics).
• Medications for sleep disorders (hypnotics).
• Medications for anxiety reduction.
• Medications for depression.
• Medications for moderate to severe pain (narcotic analgesics).
• Medications for epilepsy.
• Anesthetic medications.
• Medications for seasonal allergic rhinitis, skin eruptions, or other allergies that may cause drowsiness (sedating antihistamines).

• If you take zolpidem with antidepressants, including bupropion, desipramine, fluoxetine, sertraline, and venlafaxine, you may see things that are not real (hallucinations).
• Do not take zolpidem with fluvoxamine or ciprofloxacin.
• If you take zolpidem with narcotic analgesics, it may produce an increase in euphoria, which could lead to an increase in psychological dependence.
• Opioid medications: the use of zolpidem with opioids (powerful pain medications, substitution therapy medications, and some cough medications) increases the risk of sedation, respiratory depression, coma, and may be potentially fatal. Due to this, concomitant use should only be considered when other treatment options are not possible. However, if your doctor prescribes zolpidem with opioids, they should limit the dose and duration of concomitant use. Your doctor will monitor the appearance of signs and symptoms of respiratory depression and sedation.

Inform your doctor about all opioid medications you are taking and follow your doctor's recommended dosing schedule. It may be helpful to inform friends or family members about the signs and symptoms mentioned above. Contact your doctor when you experience these symptoms.

• Some medications that inhibit/induce certain liver enzymes (CYP450) may affect the action of zolpidem.
• Concomitant administration with ketoconazole (used to treat fungal infections) may increase sedative effects.
• Concomitant administration with rifampicin (used to treat infections) and St. John's Wort may decrease the effect of zolpidem.
• Do not use zolpidem with St. John's Wort, as it may decrease zolpidem levels in the blood.
• Do not use zolpidem with medications containing alcohol. It may increase sedative effects.

Taking Zolpidem Viatris with food and drinks

During treatment, avoid alcoholic beverages. The effect of alcohol may potentiate sedation and affect your ability to drive or use machinery. If you need additional information on this point, consult your doctor.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy:

Zolpidem is not recommended during pregnancy.

If used during pregnancy, there may be a risk of affecting the baby. Some studies have shown an increased risk of cleft lip and palate (sometimes called "hare lip") in newborns.

Reduced fetal movement and variability in fetal heart rate may occur after taking zolpidem during the second and/or third trimester of pregnancy.

If zolpidem is taken at the end of pregnancy or during delivery, your baby may experience muscle weakness, decreased body temperature, difficulty feeding, and respiratory problems (respiratory depression).

If you regularly take this medication at the end of pregnancy, your baby may develop physical dependence and may be at risk of developing withdrawal symptoms such as agitation or tremors. In this case, the newborn should be closely monitored during the postnatal period.

Lactation:

This medication passes into breast milk, so do not take zolpidem while breastfeeding your baby.

Driving and operating machines

Zolpidem is a medication that causes sleep. Do not drive or use machinery if you feel drowsy or if you notice that your attention and reaction time are reduced. Pay special attention to the start of treatment or if the dose is increased.

Zolpidem has a significant effect on the ability to drive and use machines, such as "driving while drowsy". The days you take zolpidem (as happens with other hypnotics) you should be aware of the following:

• You may feel drowsy, sleepy, dizzy, or confused.
• You may take longer to make decisions.
• You may experience blurred vision or double vision.
• Your state of alertness may be reduced.

To reduce the effects mentioned above, it is recommended to have a minimum margin of 8 hours between zolpidem administration and driving, using machinery, or any work that is done at height.

Do not consume alcohol or any other psychoactive substance while taking zolpidem, as this may increase the effects mentioned above.

Zolpidem Viatris contains lactose

If your doctor has indicated that you have an intolerance to certain sugars, consult with them before taking this medication.

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is 10 mg of zolpidem every 24 hours. A lower dose may be prescribed for some patients. Zolpidem should be taken:

• once and
• just before going to bed.

Make sure to leave a minimum of 8 hours between taking the medication and performing activities that require mental alertness.

Do not take more than 10 mg per 24 hours.

Patients over 65 years old or weakened

The recommended dose is half a tablet, that is, 5 mg. Do not exceed the recommended dose.

Patients with liver problems

The initial recommended dose is 5 mg. Your doctor may decide to increase it to 10 mg if considered safe.

Do not take zolpidem if you have severe liver problems.

Patients with respiratory problems

A lower dose is recommended for patients with respiratory problems.

Use in children and adolescents

Zolpidem should not be used in children and adolescents under 18 years old.

Each individual dose should not exceed the indicated limits, and the total daily dose should not either, unless your doctor prescribes a higher dose.

Take zolpidem just before going to bed and swallow the tablet without crushing it, with water or another non-alcoholic beverage.

Under normal conditions, it should not take more than 20 minutes to fall asleep after taking zolpidem, and it is advisable to ensure that you can rest without being woken up for at least 8 hours. Otherwise, although this happens in rare cases, it is possible that you may not remember what happened while you were awake.

In most cases, only a short-term treatment with zolpidem is needed (usually not exceeding two weeks). The maximum duration of treatment is four weeks if it includes a gradual withdrawal of the medication. Prolonging treatment will not be done without a reevaluation of your condition, as the risk of abuse and dependence increases with the duration of treatment (see section 2).

To avoid withdrawal symptoms, do not stop taking zolpidem abruptly, especially if you have been taking it for a long time.

If you estimate that the effect of zolpidem is too strong or too weak, inform your doctor or pharmacist.

If you take more Zolpidem Viatris than you should

If you have taken more zolpidem than you should, consult your doctor or pharmacist immediately.

In cases of overdose involving zolpidem alone or with other central nervous system depressants (including alcohol), cases have been reported ranging from altered consciousness to coma and more severe symptoms, including death.

In moderate cases, symptoms include: drowsiness, mental confusion, and a feeling of fatigue, exhaustion (lethargy). In more severe cases, symptoms may include: loss of coordination in movement (ataxia), decreased muscle tone (hypotonia), low blood pressure (hypotension), respiratory depression, cases of impaired consciousness up to coma, and more severe symptoms, including a fatal outcome.

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicological Information Service: Tel. 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Zolpidem Viatris

Do not take a double dose to compensate for the missed doses.

If you forget to take a dose, do not try to correct it by taking a double dose the next time, but rather continue with the normal dose.

If you interrupt treatment with Zolpidem Viatris

Abruptly stopping treatment may cause withdrawal syndrome, which manifests as headache or muscle pain, anxiety, tension, restlessness, confusion, and irritability (see section “Warnings and precautions”).

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Most patients tolerate zolpidem well, but some, especially at the beginning of treatment, may feel a bit tired or drowsy during the day.

The following criterion has been used to classify the frequency of side effects:

Very common: may affect more than 1 in 10 patients.

Common: may affect up to 1 in 10 patients.

Uncommon: may affect up to 1 in 100 patients.

Rare: may affect up to 1 in 1,000 patients.

Very rare: may affect up to 1 in 10,000 patients.

Frequency not known: cannot be estimated from available data.

A relationship between side effects and dose has been demonstrated. These effects should be less if zolpidem is administered immediately before going to bed.

These effects are more frequent in elderly patients.

Immune system disorders

Frequency not known: allergic inflammation, which can be located in feet, hands, throat, lips, and respiratory tract (angioneurotic edema).

Psychiatric disorders

Common: hallucinations, agitation, nightmares, depression.

Uncommon: confusional state, irritability, restlessness, aggression, somnambulism, euphoric mood. Zolpidem may cause somnambulism or other unusual behaviors while sleeping (such as driving, eating, calling, or having sex, etc.) without being fully awake, see "Warnings and precautions".

Rare: changes in sexual desire.

Very rare: delirium, dependence (stopping treatment may cause withdrawal symptoms or rebound effects).

Frequency not known: anger attacks, psychosis, abnormal behavior.

Nervous system disorders

Common: drowsiness, headache, dizziness, worsening of insomnia, cognitive disorders, such as anterograde amnesia (does not remember what happened while standing after taking the medication). Amnesia may be associated with inappropriate behavior.

Uncommon: paresthesia, numbness, tremor, attention alteration, speech disorder.

Rare: decreased level of consciousness.

Eye disorders

Uncommon: double vision, blurred vision.

Rare: visual impairment.

Respiratory, thoracic, and mediastinal disorders

Very rare: respiratory difficulty (respiratory depression).

Gastrointestinal disorders

Common: diarrhea, nausea, vomiting, abdominal pain.

Hepatobiliary disorders

Uncommon: increased liver enzymes.

Rare: liver damage (hepatocellular, cholestatic, or mixed injury).

Metabolism and nutrition disorders

Uncommon: appetite disorder.

Skin and subcutaneous tissue disorders

Uncommon: itching, skin rash, excessive sweating.

Rare: urticaria.

Musculoskeletal and connective tissue disorders

Common: back pain.

Uncommon: joint pain (arthralgia), muscle pain (myalgia), muscle spasms, neck pain, muscle weakness.

Infestations and infections

Common: respiratory tract infection (upper and lower respiratory tract infection).

General disorders and administration site conditions

Common: fatigue.

Rare: gait disturbances, falls (mainly in elderly patients and when not following the doctor's recommendations).

Frequency not known: product tolerance.

Depression

The use of the medication may unmask an existing depression. Since insomnia can be a symptom of depression, if insomnia persists, inform your doctor to evaluate your situation.

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: https//www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine..

Empty Section

Keep this medication out of the sight and reach of children.

This medication does not require special storage conditions.

Do not use this medication after the expiration date that appears on the packaging after the abbreviation CAD or EXP. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy.If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

Composition of Zolpidem Viatris

• The active ingredient is zolpidem. Each film-coated tablet contains 10 mg of zolpidem tartrate.
• The other components are: lactose monohydrate, microcrystalline cellulose, pregelatinized cornstarch, magnesium stearate, titanium dioxide (E-171), hypromellose 2910 (E-464), macrogol 400, polysorbate 80 (E-433) and purified water.

Appearance of the product and contents of the packaging

Zolpidem Viatris are film-coated tablets, oblong, white in color, scored and marked with “ZM” and “10” on one face and with the letter “G” on the reverse.

They are presented in blister packs containing 30 or 500 film-coated tablets.

Only some sizes of packaging may be commercially available.

Holder of the marketing authorization and responsible manufacturer

Holder of marketing authorization:

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

Responsible manufacturer:

Mylan Hungary Kft.

H-2900 Komárom

Mylan utca 1

Hungary

Last review date of this leaflet:April 2024

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) https://www.aemps.gob.es/